State Drugs Controller,
Food and Drugs Administration (FDA) Haryana |
Email ID: tanejamanmohan19@gmail.com
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Last Updated on May 16, 2024 by The Health Master
Requirements & Pathway for Grant of License for Manufacturing and Import of Medical Devices
Introduction:-
The medical device companies interested in manufacturing and import of their products in India must comply with Medical Device Rules – 2017.
- Registration pathway for device is determined by its classification and in accordance with categories listed by CDSCO, Ministry of Health & Family Welfare from time to time
Classification of Medical Devices in India as per MDR-2017:-
(i) Low risk – Class A;
(ii) Low moderate risk- Class B;
(iii) Moderate high risk- Class C;
(iv) High risk- Class D.
Mode of Application:
- Every application must be submitted Online by the applicant company alongwith prescribed fee and documents on SUGAM portal of CDSCO, Ministry of Health & Family Welfare.
Licensing Procedure/Pathway
For Class – A : Medical Device: (Step wise)
Application to SLA in MD form-3 alongwith prescribed fee
Submission of Plant Master File(PMF), Device Master File(DMF) and declaration of QMS compliance by manufacturer
Review by SLA
{No prior audit by Notified Body (NB)}
Grant of License on MD Form-5 by SLA within 45 days
Audit by NB within 120 days
For Class – B: Medical Devices: (Step wise)
Application to SLA in MD form-3 alongwith prescribed fee
QMS compliance, relevant documents as per Fourth Schedule
Audit by Notified Body for QMS compliance as per Fifth Schedule
90 days
Submission of report by NB to SLA
30 days
Review by SLA
20 days
If no non-compliance
Grant of License on MD Form-5 by SLA
For Class – C&D: Medical Devices:
Application to CLA in MD form-7 alongwith prescribed fee
QMS compliance, relevant documents as per Fourth Schedule
Scrutiny by CLA
(40 days)
Inspection by team of CDSCO Medical Device Officers and experts
(60 days)
Submission of report by team to CLA
Review by CLA
(45 days)
If no non-compliance
Grant of License on MD Form-9 by CLA
Procedure for Import of Medical Devices:
Application to CLA on MD form-14 alongwith prescribed fee and documents as per Fourth Schedule
Inspection of overseas manufacturing site is necessary
Grant of Import License on MD form-15 by CLA
Fees for Manufacturing and Import License:
Manufacturing:
Class A & B – Rs. 5000/-
Class C & D – Rs. 50000/-
Additional Items – Rs. 500/- per item
Import:
Class A – $ 1000
Class B – $ 2000
Class C & D – $ 3000
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